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NCT01489189 · ClinicalTrials.gov registry record · Phase 3

Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy

A Phase 3 study, sponsored by Jaeb Center for Health Research.

Completed
Registry status
Phase 3
Development phase
305
Enrollment target

NCT01489189: Completed Phase 3 study, sponsored by Jaeb Center for Health Research.

NCT01489189 is a Phase 3 study that has completed, run by Jaeb Center for Health Research. The registered enrollment target is 305 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01489189, a Phase 3 study, has completed, sponsored by Jaeb Center for Health Research.

COMPLETED
Registry status
Phase 3
Development phase
305 participants
Enrollment target

Study Summary

The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes that receive standard prompt PRP therapy. Secondary objectives include: * Comparing other visual function outcomes (including Humphrey visual field testing and study participant self-reports of visual function) in eyes receiving anti-VEGF with deferred PRP with those in eyes receiving prompt PRP. * Determining percent of eyes not requiring PRP when anti-VEGF is given in the absence of prompt PRP. * Comparing safety outcomes between treatment groups. * Comparing associated treatment and follow-up exam costs between treatment groups.

Primary Outcome

Visual acuity is measured as a continuous integer letter score from 0 to 100, with higher numbers indicating better visual acuity. A letter score of 85 is approximately 20/20 and a letter score of 70 is approximately 20/40, the legal unrestricted driving limit in most states. A 5-letter change for an individual is approximately equal to a 1-line change on a vision chart.

Interventions

  • OTHER Prompt Panretinal Photocoagulation
  • DRUG 0.5-mg Ranibizumab
  • OTHER Deferred panretinal photocoagulation

Trial Details

FieldValue
Enrollment Target 305 participants
Start Date 2012-03
Est. Completion 2018-02-05
Phase Phase 3
Jaeb Center for Health Research

119 total trials

What the finished NCT01489189 record still lists

NCT01489189 is an interventional study that assigns participants to a tested intervention. The registered 305 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (60% lower).

The record links to 0 conditions, and to 3 interventions - of which Prompt Panretinal Photocoagulation is the first listed.

NCT01489189 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT01489189 about?

NCT01489189 is a clinical study titled "Prompt Panretinal Photocoagulation Versus Ranibizumab+Deferred Panretinal Photocoagulation for Proliferative Diabetic Retinopathy". The primary objective of the protocol is to determine if visual acuity outcomes at 2 years in eyes with proliferative diabetic retinopathy (PDR) that receive anti-vascular endothelial growth factor (anti-VEGF) therapy with deferred panretinal photocoagulation (PRP) are non-inferior to those in eyes ...

What is the current status of trial NCT01489189?

This trial is currently completed. It is a Phase 3 study. The enrollment target is 305 participants. The study started on 2012-03. Estimated completion is 2018-02-05.

What interventions are being tested in trial NCT01489189?

The interventions under investigation include: Prompt Panretinal Photocoagulation (OTHER), 0.5-mg Ranibizumab (DRUG), Deferred panretinal photocoagulation (OTHER).

Who is sponsoring clinical trial NCT01489189?

This trial is sponsored by Jaeb Center for Health Research, which has 119 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT01489189's enrollment target sits among peer trials

305 1117th of 2000 higher than 884 of 2,000 other Phase 3 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01489189, the US trial registry maintained by the National Library of Medicine. NCT01489189 (mid enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.